Ocular implant system

ABSTRACT

The invention relates generally to medical devices and methods for reducing the intraocular pressure in an animal eye and, more particularly, to stent type devices for permitting aqueous outflow from the eye&#39;s anterior chamber and associated methods thereof for the treatment of glaucoma. Some aspects provide a self-trephining glaucoma stent and methods thereof which advantageously allow for a “one-step” procedure in which the incision and placement of the stent are accomplished by a single device and operation. This desirably allows for a faster, safer, and less expensive surgical procedure.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/301,648, filed Nov. 21, 2011, entitled OCULAR IMPLANT SYSTEMS, whichis a continuation of U.S. patent application Ser. No. 12/366,508, filedFeb. 5, 2009, entitled SELF-TREPHINING IMPLANT AND METHODS THEREOF FORTREATMENT OF OCULAR DISORDERS, now U.S. Pat. No. 8,062,244, which is adivisional of U.S. patent application Ser. No. 11/598,542, filed Nov.13, 2006, entitled IMPLANT AND METHODS THEREOF FOR TREATMENT OF OCULARDISORDERS, now U.S. Pat. No. 7,563,241, which is a continuation of U.S.patent application Ser. No. 10/118,578, filed Apr. 8, 2002, entitledGLAUCOMA STENT AND METHODS THEREOF FOR GLAUCOMA TREATMENT, now U.S. Pat.No. 7,135,009, which claims the benefit of U.S. Provisional ApplicationNo. 60/281,973, filed Apr. 7, 2001, entitled GLAUCOMA SHUNT AND METHODSTHEREOF FOR GLAUCOMA TREATMENT, the entire contents of each of which arehereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates generally to medical devices and methods forreducing the intraocular pressure in an animal eye and, moreparticularly, to shunt type devices for permitting aqueous outflow fromthe eye's anterior chamber and associated methods thereof for thetreatment of glaucoma.

2. Description of the Related Art

The human eye is a specialized sensory organ capable of light receptionand able to receive visual images. The trabecular meshwork serves as adrainage channel and is located in anterior chamber angle formed betweenthe iris and the cornea. The trabecular meshwork maintains a balancedpressure in the anterior chamber of the eye by draining aqueous humorfrom the anterior chamber.

About two percent of people in the United States have glaucoma. Glaucomais a group of eye diseases encompassing a broad spectrum of clinicalpresentations, etiologies, and treatment modalities. Glaucoma causespathological changes in the optic nerve, visible on the optic disk, andit causes corresponding visual field loss, resulting in blindness ifuntreated. Lowering intraocular pressure is the major treatment goal inall glaucomas.

In glaucomas associated with an elevation in eye pressure (intraocularhypertension), the source of resistance to outflow is mainly in thetrabecular meshwork. The tissue of the trabecular meshwork allows theaqueous humor (“aqueous”) to enter Schlemm's canal, which then emptiesinto aqueous collector channels in the posterior wall of Schlemm's canaland then into aqueous veins, which form the episcleral venous system.Aqueous humor is a transparent liquid that fills the region between thecornea, at the front of the eye, and the lens. The aqueous humor iscontinuously secreted by the ciliary body around the lens, so there is aconstant flow of aqueous humor from the ciliary body to the eye's frontchamber. The eye's pressure is determined by a balance between theproduction of aqueous and its exit through the trabecular meshwork(major route) or uveal scleral outflow (minor route). The trabecularmeshwork is located between the outer rim of the iris and the back ofthe cornea, in the anterior chamber angle. The portion of the trabecularmeshwork adjacent to Schlemm's canal (the juxtacanilicular meshwork)causes most of the resistance to aqueous outflow.

Glaucoma is grossly classified into two categories: closed-angleglaucoma, also known as angle closure glaucoma, and open-angle glaucoma.Closed-angle glaucoma is caused by closure of the anterior chamber angleby contact between the iris and the inner surface of the trabecularmeshwork. Closure of this anatomical angle prevents normal drainage ofaqueous humor from the anterior chamber of the eye.

Open-angle glaucoma is any glaucoma in which the angle of the anteriorchamber remains open, but the exit of aqueous through the trabecularmeshwork is diminished. The exact cause for diminished filtration isunknown for most cases of open-angle glaucoma. Primary open-angleglaucoma is the most common of the glaucomas, and it is oftenasymptomatic in the early to moderately advanced stage. Patients maysuffer substantial, irreversible vision loss prior to diagnosis andtreatment. However, there are secondary open-angle glaucomas which mayinclude edema or swelling of the trabecular spaces (e.g., fromcorticosteroid use), abnormal pigment dispersion, or diseases such ashyperthyroidism that produce vascular congestion.

Current therapies for glaucoma are directed at decreasing intraocularpressure. Medical therapy includes topical ophthalmic drops or oralmedications that reduce the production or increase the outflow ofaqueous. However, these drug therapies for glaucoma are sometimesassociated with significant side effects, such as headache, blurredvision, allergic reactions, death from cardiopulmonary complications,and potential interactions with other drugs. When drug therapy fails,surgical therapy is used. Surgical therapy for open-angle glaucomaconsists of laser trabeculoplasty, trabeculectomy, and implantation ofaqueous shunts after failure of trabeculectomy or if trabeculectomy isunlikely to succeed. Trabeculectomy is a major surgery that is widelyused and is augmented with topically applied anticancer drugs, such as5-flurouracil or mitomycin-C to decrease scarring and increase thelikelihood of surgical success.

Approximately 100,000 trabeculectomies are performed on Medicare-agepatients per year in the United States. This number would likelyincrease if the morbidity associated with trabeculectomy could bedecreased. The current morbidity associated with trabeculectomy consistsof failure (10-15%); infection (a lifelong risk of 2-5%); choroidalhemorrhage, a severe internal hemorrhage from low intraocular pressure,resulting in visual loss (1%); cataract formation; and hypotonymaculopathy (potentially reversible visual loss from low intraocularpressure).

For these reasons, surgeons have tried for decades to develop a workablesurgery for the trabecular meshwork.

The surgical techniques that have been tried and practiced aregoniotomy/trabeculotomy and other mechanical disruptions of thetrabecular meshwork, such as trabeculopuncture, goniophotoablation,laser trabecular ablation, and goniocurretage. These are all majoroperations and are briefly described below.

Goniotomy/Trabeculotomy: Goniotomy and trabeculotomy are simple anddirected techniques of microsurgical dissection with mechanicaldisruption of the trabecular meshwork. These initially had earlyfavorable responses in the treatment of open-angle glaucoma. However,long-term review of surgical results showed only limited success inadults. In retrospect, these procedures probably failed due to cellularrepair and fibrosis mechanisms and a process of “filling in.” Filling inis a detrimental effect of collapsing and closing in of the createdopening in the trabecular meshwork. Once the created openings close, thepressure builds back up and the surgery fails.

Trabeculopuncture: Q-switched Neodynium (Nd) YAG lasers also have beeninvestigated as an optically invasive technique for creatingfull-thickness holes in trabecular meshwork. However, the relativelysmall hole created by this trabeculopuncture technique exhibits afilling-in effect and fails.

Goniophotoablation/Laser Trabecular Ablation: Goniophotoablation isdisclosed by Berlin in U.S. Pat. No. 4,846,172 and involves the use ofan excimer laser to treat glaucoma by ablating the trabecular meshwork.This was demonstrated not to succeed by clinical trial. Hill et al. usedan Erbium:YAG laser to create full-thickness holes through trabecularmeshwork (Hill et al., Lasers in Surgery and Medicine 11:341-346, 1991).This technique was investigated in a primate model and a limited humanclinical trial at the University of California, Irvine. Althoughmorbidity was zero in both trials, success rates did not warrant furtherhuman trials. Failure was again from filling in of surgically createddefects in the trabecular meshwork by repair mechanisms. Neither ofthese is a viable surgical technique for the treatment of glaucoma.

Goniocurretage: This is an ab interno (from the inside), mechanicallydisruptive technique that uses an instrument similar to a cyclodialysisspatula with a microcurrette at the tip. Initial results were similar totrabeculotomy: it failed due to repair mechanisms and a process offilling in.

Although trabeculectomy is the most commonly performed filteringsurgery, viscocanulostomy (VC) and non penetrating trabeculectomy (NPT)are two new variations of filtering surgery. These are ab externo (fromthe outside), major ocular procedures in which Schlemm's canal issurgically exposed by making a large and very deep scleral flap. In theVC procedure, Schlemm's canal is cannulated and viscoelastic substanceinjected (which dilates Schlemm's canal and the aqueous collectorchannels). In the NPT procedure, the inner wall of Schlemm's canal isstripped off after surgically exposing the canal.

Trabeculectomy, VC, and NPT involve the formation of an opening or holeunder the conjunctiva and scleral flap into the anterior chamber, suchthat aqueous humor is drained onto the surface of the eye or into thetissues located within the lateral wall of the eye. These surgicaloperations are major procedures with significant ocular morbidity. Whentrabeculectomy, VC, and NPT are thought to have a low chance forsuccess, a number of implantable drainage devices have been used toensure that the desired filtration and outflow of aqueous humor throughthe surgical opening will continue. The risk of placing a glaucomadrainage device also includes hemorrhage, infection, and diplopia(double vision).

Examples of implantable shunts and surgical methods for maintaining anopening for the release of aqueous humor from the anterior chamber ofthe eye to the sclera or space beneath the conjunctiva have beendisclosed in, for example, U.S. Pat. No. 6,059,772 to Hsia et al., andU.S. Pat. No. 6,050,970 to Baerveldt.

All of the above surgeries and variations thereof have numerousdisadvantages and moderate success rates. They involve substantialtrauma to the eye and require great surgical skill in creating a holethrough the full thickness of the sclera into the subconjunctival space.The procedures are generally performed in an operating room and have aprolonged recovery time for vision.

The complications of existing filtration surgery have promptedophthalmic surgeons to find other approaches to lowering intraocularpressure.

The trabecular meshwork and juxtacanilicular tissue together provide themajority of resistance to the outflow of aqueous and, as such, arelogical targets for surgical removal in the treatment of open-angleglaucoma. In addition, minimal amounts of tissue are altered andexisting physiologic outflow pathways are utilized.

As reported in Arch. Ophthalm. (2000) 118:412, glaucoma remains aleading cause of blindness, and filtration surgery remains an effective,important option in controlling the disease. However, modifying existingfiltering surgery techniques in any profound way to increase theireffectiveness appears to have reached a dead end. The article furtherstates that the time has come to search for new surgical approaches thatmay provide better and safer care for patients with glaucoma.

Therefore, there is a great clinical need for a method of treatingglaucoma that is faster, safer, and less expensive than currentlyavailable modalities.

SUMMARY OF THE INVENTION

The trabecular meshwork and juxtacanilicular tissue together provide themajority of resistance to the outflow of aqueous and, as such, arelogical targets for surgical approach in the treatment of glaucoma.Various embodiments of glaucoma shunts are disclosed herein for aqueousto exit through the trabecular meshwork (major route) or uveal scleraloutflow (minor route) or other route effective to reduce intraocularpressure (IOP).

Glaucoma surgical morbidity would greatly decrease if one were to bypassthe focal resistance to outflow of aqueous only at the point ofresistance, and to utilize remaining, healthy aqueous outflowmechanisms. This is in part because episcleral aqueous humor exerts abackpressure that prevents intraocular pressure from going too low, andone could thereby avoid hypotony. Thus, such a surgery would virtuallyeliminate the risk of hypotony-related maculopathy and choroidalhemorrhage. Furthermore, visual recovery would be very rapid, and therisk of infection would be very small, reflecting a reduction inincidence from 2-5% to about 0.05%.

Copending U.S. application Ser. No. 09/549,350, filed Apr. 14, 2000,entitled APPARATUS AND METHOD FOR TREATING GLAUCOMA, and copending U.S.application Ser. No. 09/704,276, filed Nov. 1, 2000, entitled GLAUCOMATREATMENT DEVICE, disclose devices and methods of placing a trabecularshunt ab interno, i.e., from inside the anterior chamber through thetrabecular meshwork, into Schlemm's canal. The entire contents of eachof these copending patent applications are hereby incorporated byreference herein. The invention encompasses both ab interno and abexterno glaucoma shunts or stents and methods thereof.

Techniques performed in accordance with aspects herein may be referredto generally as “trabecular bypass surgery.” Advantages of this type ofsurgery include lowering intraocular pressure in a manner which issimple, effective, disease site-specific, and can potentially beperformed on an outpatient basis.

Generally, trabecular bypass surgery (TBS) creates an opening, a slit,or a hole through trabecular meshwork with minor microsurgery. TBS hasthe advantage of a much lower risk of choroidal hemorrhage and infectionthan prior techniques, and it uses existing physiologic outflowmechanisms. In some aspects, this surgery can potentially be performedunder topical or local anesthesia on an outpatient basis with rapidvisual recovery. To prevent “filling in” of the hole, a biocompatibleelongated device is placed within the hole and serves as a stent. U.S.patent application Ser. No. 09/549,350, filed Apr. 14, 2000, the entirecontents of which are hereby incorporated by reference herein, disclosestrabecular bypass surgery.

As described in U.S. patent application. Ser. No. 09/549,350, filed Apr.14, 2000, and U.S. application Ser. No. 09/704,276, filed Nov. 1, 2000,the entire contents each one of which are hereby incorporated byreference herein, a trabecular shunt or stent for transporting aqueoushumor is provided. The trabecular stent includes a hollow, elongatetubular element, having an inlet section and an outlet section. Theoutlet section may optionally include two segments or elements, adaptedto be positioned and stabilized inside Schlemm's canal. In oneembodiment, the device appears as a “T” shaped device.

In one aspect of the invention, a delivery apparatus (or “applicator”)is used for placing a trabecular stent through a trabecular meshwork ofan eye. Certain embodiments of such a delivery apparatus are disclosedin copending U.S. application Ser. No. 10/101,548, filed Mar. 18, 2002,entitled APPLICATOR AND METHODS FOR PLACING A TRABECULAR SHUNT FORGLAUCOMA TREATMENT, and U.S. Provisional Application No. 60/276,609,filed Mar. 16, 2001, entitled APPLICATOR AND METHODS FOR PLACING ATRABECULAR SHUNT FOR GLAUCOMA TREATMENT, the entire contents of each oneof which are hereby incorporated by reference herein.

The stent has an inlet section and an outlet section. The deliveryapparatus includes a handpiece, an elongate tip, a holder and anactuator. The handpiece has a distal end and a proximal end. Theelongate tip is connected to the distal end of the handpiece. Theelongate tip has a distal portion and is configured to be placed througha corneal incision and into an anterior chamber of the eye. The holderis attached to the distal portion of the elongate tip. The holder isconfigured to hold and release the inlet section of the trabecularstent. The actuator is on the handpiece and actuates the holder torelease the inlet section of the trabecular stent from the holder. Whenthe trabecular stent is deployed from the delivery apparatus into theeye, the outlet section is positioned in substantially oppositedirections inside Schlemm's canal. In one embodiment, a deploymentmechanism within the delivery apparatus includes a push-pull typeplunger.

Some aspects of the invention relate to devices for reducing intraocularpressure by providing outflow of aqueous from an anterior chamber of aneye. The device generally comprises an elongated tubular member andcutting means. The tubular member is adapted for extending through atrabecular meshwork of the eye. The tubular member generally comprises alumen having an inlet port and an outlet port for providing a flowpathway. The cutting means is mechanically connected to the tubularmember for creating an incision in the trabecular meshwork for receivingat least a portion of the tubular member.

In one aspect, a self-trephining glaucoma stent is provided for reducingand/or balancing intraocular pressure in an eye. The stent generallycomprises a snorkel and a curved blade. The snorkel generally comprisesan upper seat for stabilizing said stent within the eye, a shank and alumen. The shank is mechanically connected to the seat and is adaptedfor extending through a trabecular meshwork of the eye. The lumenextends through the snorkel and has at least one inlet flow port and atleast one outlet flow port. The blade is mechanically connected to thesnorkel. The blade generally comprises a cutting tip proximate adistal-most point of the blade for making an incision in the trabecularmeshwork for receiving the shank.

Some aspects of the invention relate to methods of implanting atrabecular stent device in an eye. In one aspect, the device has asnorkel mechanically connected to a blade. The blade is advanced bladethrough a trabecular meshwork of the eye to cut the trabecular meshworkand form an incision therein. At least a portion of the snorkel isinserted in the incision to implant the device in the eye.

Some aspects provide a self-trephining glaucoma stent and methodsthereof which advantageously allow for a “one-step” procedure in whichthe incision and placement of the stent are accomplished by a singledevice and operation. This desirably allows for a faster, safer, andless expensive surgical procedure. In any of the embodiments, fiducialmarkings, indicia, or the like and/or positioning of the stent device ina preloaded applicator may be used for proper orientation and alignmentof the device during implantation.

Among the advantages of trabecular bypass surgery is its simplicity. Themicrosurgery may potentially be performed on an outpatient basis withrapid visual recovery and greatly decreased morbidity. There is a lowerrisk of infection and choroidal hemorrhage, and there is a fasterrecovery, than with previous techniques.

For purposes of summarizing the invention, certain aspects, advantagesand novel features of the invention have been described herein above. Ofcourse, it is to be understood that not necessarily all such advantagesmay be achieved in accordance with any particular embodiment of theinvention. Thus, the invention may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught or suggested herein without necessarily achieving otheradvantages as may be taught or suggested herein.

All of these embodiments are intended to be within the scope of theinvention herein disclosed. These and other embodiments of the inventionwill become readily apparent to those skilled in the art from thefollowing detailed description of the preferred embodiments havingreference to the attached figures, the invention not being limited toany particular preferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus summarized the general nature of the invention and some ofits features and advantages, certain preferred embodiments andmodifications thereof will become apparent to those skilled in the artfrom the detailed description herein having reference to the figuresthat follow, of which:

FIG. 1 is a coronal cross-sectional view of an eye;

FIG. 2 is an enlarged cross-sectional view of an anterior chamber angleof the eye of FIG. 1;

FIG. 3 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 4 is a side elevation view of the stent of FIG. 3;

FIG. 5 is a top plan view of the stent of FIG. 3;

FIG. 6 is a bottom plan view of the stent of FIG. 3;

FIG. 7 is a front end view of the stent of FIG. 3 (along line 7-7 ofFIG. 4);

FIG. 8 is a rear end view of the stent of FIG. 3 (along line 8-8 of FIG.4);

FIG. 9 is an enlarged top plan view of a cutting tip of the stent ofFIG. 3;

FIG. 10 is a top plan view of one exemplary embodiment of a snorkel topseating surface;

FIG. 11 is a top plan view of another exemplary embodiment of a snorkeltop seating surface;

FIG. 12 is a top plan view of yet another exemplary embodiment of asnorkel top seating surface;

FIG. 13 is a top plan view of still another exemplary embodiment of asnorkel top seating surface;

FIG. 14 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with another embodiment of the invention;

FIG. 15 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with a further embodiment of the invention;

FIG. 16 is a side elevation view of a glaucoma stent having features andadvantages in accordance with one embodiment of the invention;

FIG. 17 is a top plan view of the stent of FIG. 16;

FIG. 18 is a bottom plan view of the stent of FIG. 16;

FIG. 19 is a front end view along line 19-19 of FIG. 16;

FIG. 20 is a rear end view along line 20-20 of FIG. 16;

FIG. 21 is a side elevation view of a glaucoma stent having features andadvantages in accordance with one embodiment of the invention;

FIG. 22 is a top plan view of the stent of FIG. 21;

FIG. 23 is a bottom plan view of the stent of FIG. 21;

FIG. 24 is a front end view along line 24-24 of FIG. 21;

FIG. 25 is a rear end view along line 25-25 of FIG. 21;

FIG. 26 is a front elevation view of a glaucoma stent having featuresand advantages in accordance with one embodiment of the invention;

FIG. 27 is a side elevation view along line 27-27 of FIG. 26;

FIG. 28 is a rear end view along line 28-28 of FIG. 26;

FIG. 29 is a simplified partial view of an eye illustrating the temporalimplantation of a glaucoma stent using a delivery apparatus havingfeatures and advantages in accordance with one embodiment of theinvention;

FIG. 30 is an oblique elevational view of an articulating arm stentdelivery/retrieval apparatus having features and advantages inaccordance with one embodiment of the invention;

FIG. 31 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent using a delivery apparatus crossingthrough the eye anterior chamber;

FIG. 32 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 33 is a detailed enlarged view of the barbed pin of FIG. 32;

FIG. 34 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 35 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 36 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 37 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 38 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 39 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 40 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 41 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 42 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with one embodiment of the invention;

FIG. 43 is a simplified partial view of an eye illustrating theimplantation of a valved tube stent device having features andadvantages in accordance with one embodiment of the invention;

FIG. 44 is a simplified partial view of an eye illustrating theimplantation of an osmotic membrane device having features andadvantages in accordance with one embodiment of the invention;

FIG. 45 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent using ab externo procedure havingfeatures and advantages in accordance with one embodiment of theinvention;

FIG. 46 is a simplified partial view of an eye illustrating theimplantation of a glaucoma stent having features and advantages inaccordance with a modified embodiment of the invention; and

FIG. 47 is a simplified partial view of an eye illustrating theimplantation of a drug release implant having features and advantages inaccordance with one embodiment of the invention.

FIG. 48 is an oblique elevational view of a trabecular shunt applicatorwith a retractable blade mechanism.

FIGS. 49A and 49B are schematic cross sections of a trabecular punchdevice.

FIGS. 50A and 50B are elevational views of a control arm andtrabeculotomy device for the trabecular shunt applicator.

FIGS. 51A through 51C are schematic oblique elevational views of varioustrabecular meshwork punching and drilling devices.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The preferred embodiments of the invention described herein relateparticularly to surgical and therapeutic treatment of glaucoma throughreduction of intraocular pressure. While the description sets forthvarious embodiment specific details, it will be appreciated that thedescription is illustrative only and should not be construed in any wayas limiting the invention. Furthermore, various applications of theinvention, and modifications thereto, which may occur to those who areskilled in the art, are also encompassed by the general conceptsdescribed herein.

FIG. 1 is a cross-sectional view of an eye 10, while FIG. 2 is aclose-up view showing the relative anatomical locations of a trabecularmeshwork 21, an anterior chamber 20, and a Schlemm's canal 22. A sclera11 is a thick collagenous tissue which covers the entire eye 10 except aportion which is covered by a cornea 12.

Referring to FIGS. 1 and 2, the cornea 12 is a thin transparent tissuethat focuses and transmits light into the eye and through a pupil 14,which is a circular hole in the center of an iris 13 (colored portion ofthe eye). The cornea 12 merges into the sclera 11 at a juncture referredto as a limbus 15. A ciliary body 16 extends along the interior of thesclera 11 and is coextensive with a choroid 17. The choroid 17 is avascular layer of the eye 10, located between the sclera 11 and a retina18. An optic nerve 19 transmits visual information to the brain and isthe anatomic structure that is progressively destroyed by glaucoma.

Still referring to FIGS. 1 and 2, the anterior chamber 20 of the eye 10,which is bound anteriorly by the cornea 12 and posteriorly by the iris13 and a lens 26, is filled with aqueous humor (hereinafter referred toas “aqueous”). Aqueous is produced primarily by the ciliary body 16,then moves anteriorly through the pupil 14 and reaches an anteriorchamber angle 25, formed between the iris 13 and the cornea 12.

As best illustrated by the drawing of FIG. 2, in a normal eye, aqueousis removed from the anterior chamber 20 through the trabecular meshwork21. Aqueous passes through the trabecular meshwork 21 into Schlemm'scanal 22 and thereafter through a plurality of aqueous veins 23, whichmerge with blood-carrying veins, and into systemic venous circulation.Intraocular pressure is maintained by an intricate balance betweensecretion and outflow of aqueous in the manner described above. Glaucomais, in most cases, characterized by an excessive buildup of aqueous inthe anterior chamber 20 which leads to an increase in intraocularpressure. Fluids are relatively incompressible, and thus intraocularpressure is distributed relatively uniformly throughout the eye 10.

As shown in FIG. 2, the trabecular meshwork 21 is adjacent a smallportion of the sclera 11. Exterior to the sclera 11 is a conjunctiva 24.Traditional procedures that create a hole or opening for implanting adevice through the tissues of the conjunctiva 24 and sclera 11 involveextensive surgery, as compared to surgery for implanting a device, asdescribed herein, which ultimately resides entirely within the confinesof the sclera 11 and cornea 12.

Self-Trephining Glaucoma Stent

FIG. 3 generally illustrates the use of one embodiment of a trabecularstenting device 30 for establishing an outflow pathway, passing throughthe trabecular meshwork 21, which is discussed in greater detail below.FIGS. 4-9 are different views of the stent 30. Advantageously, and asdiscussed in further detail later herein, the self-trephining-stentallows a one-step procedure to make an incision in the trabecular mesh21 and place the stent or implant 30 at the desired or predeterminedposition within the eye 10. Desirably, this facilitates the overallsurgical procedure.

In the illustrated embodiment of FIGS. 3-9, the shunt or stent 30generally comprises a snorkel 32 and a main body portion or blade 34.The snorkel 32 and blade 34 are mechanically connected to or inmechanical communication with one another. The stent 30 and/or the bodyportion 34 have a generally longitudinal axis 36.

In the illustrated embodiment of FIGS. 3-9, the stent 30 comprises anintegral unit. In modified embodiments, the stent 30 may comprise anassembly of individual pieces or components. For example, the stent 30may comprise an assembly of the snorkel 32 and blade 34.

In the illustrated embodiment of FIGS. 3-9, the snorkel 32 is in theform of a generally elongate tubular member and generally comprises anupper seat, head or cap portion 38, a shank portion 40 and a lumen orpassage 42 extending therethrough. The seat 38 is mechanically connectedto or in mechanical communication with the shank 40 which is alsomechanically connected to or in mechanical communication with the blade34. The snorkel 32 and/or the lumen 42 have a generally longitudinalaxis 43.

In the illustrated embodiment of FIGS. 3-9, the seat 38 is generallycircular in shape and has an upper surface 44 and a lower surface 46which, as shown in FIG. 3, abuts or rests against the trabecularmeshwork 21 to stabilize the glaucoma stent 30 within the eye 10. Inmodified embodiments, the seat 38 may efficaciously be shaped in othersuitable manners, as required or desired, giving due consideration tothe goals of stabilizing the glaucoma stent 30 within the eye 10 and/orof achieving one or more of the benefits and advantages as taught orsuggested herein. For example, the seat 38 may be shaped in otherpolygonal or non-polygonal shapes and/or comprise one or more ridgeswhich extend radially outwards, among other suitable retention devices.

In the illustrated embodiment of FIGS. 3-9, and as best seen in the topview of FIG. 5, the seat top surface 44 comprises fiducial marks orindicia 48. These marks or indicia 48 facilitate and ensure properorientation and alignment of the stent 30 when implanted in the eye 10.The marks or indicia 48 may comprise visual differentiation means suchas color contrast or be in the form of ribs, grooves, or the like.Alternatively, or in addition, the marks 48 may provide tactile sensoryfeedback to the surgeon. Also, the seat 38 and/or the seat top surface44 may be configured in predetermined shapes aligned with the blade 34and/or longitudinal axis 36 to provide for proper orientation of thestent device 30 within the eye 10. For example, the seat top surface 44may be oval or ellipsoidal (FIG. 10), rectangular (FIG. 11), hexagonal(FIG. 12), among other suitable shapes (e.g. FIG. 13).

In the illustrated embodiment of FIGS. 3-9, and as indicated above, theseat bottom surface 46 abuts or rests against the trabecular meshwork 21to stabilize and retain the glaucoma stent 30 within the eye 10. Forstabilization purposes, the seat bottom surface 46 may comprise astudded surface, a ribbed surface, a surface with pillars, a texturedsurface, or the like.

In the illustrated embodiment of FIGS. 3-9, the snorkel shank 40 isgenerally cylindrical in shape. With the stent 30 implanted, as shown inFIG. 3, the shank 40 is generally positioned in an incision or cavity 50formed in the trabecular meshwork 21 by the self-trephining stent 30.Advantageously, and as discussed further below, this single step offorming the cavity 50 by the stent 30 itself and placing the stent 30 inthe desired position facilitates and expedites the overall surgicalprocedure. In modified embodiments, the snorkel shank 40 mayefficaciously be shaped in other suitable manners, as required ordesired. For example, the shank 40 may be in the shape of otherpolygonal or non-polygonal shapes, such as, oval, elliposoidal, and thelike.

In the illustrated embodiment of FIGS. 3-9, and as best seen in FIG. 3,the shank 40 has an outer surface 52 in contact with the trabecularmeshwork 21 surrounding the cavity 50. For stabilization purposes, theshank outer surface 52 may comprise a studded surface, a ribbed surface,a surface with pillars, a textured surface, or the like.

In the illustrated embodiment of FIGS. 3-9, the snorkel lumen 42 has aninlet port, opening or orifice 54 at the seat top surface 44 and anoutlet port, opening or orifice 56 at the junction of the shank 40 andblade 34. The lumen 42 is generally cylindrical in shape, that is, ithas a generally circular cross-section, and its ports 54, 56 aregenerally circular in shape. In modified embodiments, the lumen 42 andports 54, 56 may be efficaciously shaped in other manners, as requiredor desired, giving due consideration to the goals of providingsufficient aqueous outflow and/or of achieving one or more of thebenefits and advantages as taught or suggested herein. For example, thelumen 42 and/or one or both ports 54, 56 may be shaped in the form ofovals, ellipsoids, and the like, or the lumen 42 may have a tapered orstepped configuration.

Referring in particular to FIG. 3, aqueous from the anterior chamber 20flows into the lumen 42 through the inlet port 54 (as generallyindicated by arrow 58) and out of the outlet port 56 and into Schlemm'scanal 22 (as generally indicated by arrows 60) to lower and/or balancethe intraocular pressure (IOP). In another embodiment, as discussed infurther detail below, one or more of the outlet ports may be configuredto face in the general direction of the stent longitudinal axis 36. Inmodified embodiments, the snorkel 32 may comprise more than one lumen,as needed or desired, to facilitate multiple aqueous outflowtransportation into Schlemm's canal 22.

In the illustrated embodiment of FIGS. 3-9, the blade longitudinal axis36 and the snorkel longitudinal axis 43 are generally perpendicular toone another. Stated differently, the projections of the axes 36, 43 on acommon plane which is not perpendicular to either of the axes 36, 43intersect at 90°. The blade longitudinal axis 36 and the snorkellongitudinal axis 43 may intersect one another or may be offset from oneanother.

In the illustrated embodiment of FIGS. 3-9, the main body portion orblade 34 is a generally curved elongated sheet- or plate-like structurewith an upper curved surface 62 and a lower curved surface 64 whichdefines a trough or open face channel 66. The perimeter of the blade 34is generally defined by a curved proximal edge 68 proximate to thesnorkel 32, a curved distal edge 70 spaced from the proximal edge 68 bya pair of generally straight lateral edges 72, 74 with the first lateraledge 72 extending beyond the second lateral edge 74 and intersectingwith the distal edge 70 at a distal-most point 76 of the blade 34proximate a blade cutting tip 78.

In the illustrated embodiment of FIGS. 3-9, and as shown in the enlargedview of FIG. 9, the cutting tip 78 comprises a first cutting edge 80 onthe distal edge 70 and a second cutting edge 82 on the lateral edge 72.The cutting edges 80, 82 preferably extend from the distal-most point 76of the blade 34 and comprise at least a respective portion of the distaledge 70 and lateral edge 72. The respective cutting edges 80, 82 areformed at the sharp edges of respective beveled or tapered surfaces 84,86. In one embodiment, the remainder of the distal edge 70 and lateraledge 72 are dull or rounded. In one embodiment, the tip 78 proximate tothe distal-most end 76 is curved slightly inwards, as indicatedgenerally by the arrow 88 in FIG. 5 and arrow 88 (pointed perpendicularand into the plane of the paper) in FIG. 9, relative to the adjacentcurvature of the blade 34.

In modified embodiments, suitable cutting edges may be provided onselected portions of one or more selected blade edges 68, 70, 72, 74with efficacy, as needed or desired, giving due consideration to thegoals of providing suitable cutting means on the stent 30 foreffectively cutting through the trabecular meshwork 21 (FIG. 3) and/orof achieving one or more of the benefits and advantages as taught orsuggested herein.

Referring in particular to FIG. 9, in one embodiment, the ratio betweenthe lengths of the cutting edges 80, 82 is about 2:1. In anotherembodiment, the ratio between the lengths of the cutting edges 80, 82 isabout 1:1. In yet another embodiment, the ratio between the lengths ofthe cutting edges 80, 82 is about 1:2. In modified embodiments, thelengths of the cutting edges 80, 82 may be efficaciously selected inother manners, as required or desired, giving due consideration to thegoals of providing suitable cutting means on the stent 30 foreffectively cutting through the trabecular meshwork 21 (FIG. 3) and/orof achieving one or more of the benefits and advantages as taught orsuggested herein.

Still referring in particular to FIG. 9, in one embodiment, the ratiobetween the lengths of the cutting edges 80, 82 is in the range fromabout 2:1 to about 1:2. In another embodiment, the ratio between thelengths of the cutting edges 80, 82 is in the range from about 5:1 toabout 1:5. In yet another embodiment, the ratio between the lengths ofthe cutting edges 80, 82 is in the range from about 10:1 to about 1:10.In modified embodiments, the lengths of the cutting edges 80, 82 may beefficaciously selected in other manners, as required or desired, givingdue consideration to the goals of providing suitable cutting means onthe stent 30 for effectively cutting through the trabecular meshwork 21(FIG. 3) and/or of achieving one or more of the benefits and advantagesas taught or suggested herein.

As shown in the top view of FIG. 9, the cutting edge 80 (and/or thedistal end 70) and the cutting edge 82 (and/or the lateral edge 72)intersect at an angle θ. Stated differently, θ is the angle between theprojections of the cutting edge 80 (and/or the distal end 70) and thecutting edge 82 (and/or the lateral edge 72) on a common plane which isnot perpendicular to either of these edges.

Referring to in particular to FIG. 9, in one embodiment, the angle θ isabout 50°. In another embodiment, the angle θ is in the range from about40° to about 60°. In yet another embodiment, the angle θ is in the rangefrom about 30° to about 70°. In modified embodiments, the angle θ may beefficaciously selected in other manners, as required or desired, givingdue consideration to the goals of providing suitable cutting means onthe stent 30 for effectively cutting through the trabecular meshwork 21(FIG. 3) and/or of achieving one or more of the benefits and advantagesas taught or suggested herein.

The stent 30 of the embodiments disclosed herein can be dimensioned in awide variety of manners. Referring in particular to FIG. 3, the depth ofSchlemm's canal 22 is typically about less than 400 microns (μm).Accordingly, the stent blade 34 is dimensioned so that the height of theblade 34 (referred to as H₄₁ in FIG. 4) is typically less than about 400μm. The snorkel shank 40 is dimensioned so that it has a length(referred to as L₄₁ in FIG. 4) typically in the range from about 100 μmto about 300 μm which is roughly the typical range of the thickness ofthe trabecular meshwork 21.

Of course, as the skilled artisan will appreciate, that with the stent30 implanted, the blade 34 may rest at any suitable position withinSchlemm's canal 22. For example, the blade 34 may be adjacent to a frontwall 90 of Schlemm's canal 22 (as shown in FIG. 3), or adjacent to aback wall 92 of Schlemm's canal 22, or at some intermediate locationtherebetween, as needed or desired. Also, the snorkel shank 40 mayextend into Schlemm's canal 22. The length of the snorkel shank 40and/or the dimensions of the blade 34 may be efficaciously adjusted toachieve the desired implant positioning.

The trabecular stenting device 30 (FIGS. 3-9) of the exemplaryembodiment may be manufactured or fabricated by a wide variety oftechniques. These include, without limitation, by molding,thermo-forming, or other micro-machining techniques, among othersuitable techniques.

The trabecular stenting device 30 preferably comprises a biocompatiblematerial such that inflammation arising due to irritation between theouter surface of the device 30 and the surrounding tissue is minimized.Biocompatible materials which may be used for the device 30 preferablyinclude, but are not limited to, titanium, titanium alloys, medicalgrade silicone, e.g., Silastic™, available from Dow Corning Corporationof Midland, Mich.; and polyurethane, e.g., Pellethane™, also availablefrom Dow Corning Corporation.

In other embodiments, the stent device 30 may comprise other types ofbiocompatible material, such as, by way of example, polyvinyl alcohol,polyvinyl pyrolidone, collagen, heparinized collagen,polytetrafluoroethylene, expanded polytetrafluoroethylene, fluorinatedpolymer, fluorinated elastomer, flexible fused silica, polyolefin,polyester, polysilicon, and/or a mixture of the aforementionedbiocompatible materials, and the like. In still other embodiments,composite biocompatible material may be used, wherein a surface materialmay be used in addition to one or more of the aforementioned materials.For example, such a surface material may include polytetrafluoroethylene(PTFE) (such as Teflon™), polyimide, hydrogel, heparin, therapeuticdrugs (such as beta-adrenergic antagonists and other anti-glaucomadrugs, or antibiotics), and the like.

In an exemplary embodiment of the trabecular meshwork surgery, thepatient is placed in the supine position, prepped, draped andanesthetized as necessary. In one embodiment, a small (less than about 1mm) incision, which may be self-sealing is made through the cornea 12.The corneal incision can be made in a number of ways, for example, byusing a micro-knife, among other tools.

An applicator or delivery apparatus is used to advance the glaucomastent 30 through the corneal incision and to the trabecular meshwork 21.Some embodiments of such a delivery apparatus are disclosed in copendingU.S. application Ser. No. 10/101,548, filed Mar. 18, 2002, entitledAPPLICATOR AND METHODS FOR PLACING A TRABECULAR SHUNT FOR GLAUCOMATREATMENT, and U.S. Provisional Application No. 60/276,609, filed Mar.16, 2001, entitled APPLICATOR AND METHODS FOR PLACING A TRABECULAR SHUNTFOR GLAUCOMA TREATMENT, the entire contents of each one of which arehereby incorporated by reference herein. Some embodiments of a deliveryapparatus are also discussed in further detail later herein.Gonioscopic, microscopic, or endoscopic guidance may be used during thetrabecular meshwork surgery.

With the device 30 held by the delivery apparatus, the blade 34 of theself-trephining glaucoma stent device 30 is used to cut and/or displacethe material of the trabecular meshwork 21. The snorkel shank 40 mayalso facilitate in removal of this material during implantation. Thedelivery apparatus is withdrawn once the device 30 has been implanted inthe eye 10. As shown in FIG. 3, once proper implantation has beenaccomplished the snorkel seat 38 rests on a top surface 94 of thetrabecular meshwork 21, the snorkel shank 40 extends through the cavity50 (created by the device 30) in the trabecular meshwork 21, and theblade extends inside Schlemm's canal 22.

Advantageously, the embodiments of the self-trephining stent device ofthe invention allow for a “one-step” procedure to make an incision inthe trabecular meshwork and to subsequently implant the stent in theproper orientation and alignment within the eye to allow outflow ofaqueous from the anterior chamber through the stent and into Schlemm'scanal to lower and/or balance the intraocular pressure (IOP). Desirably,this provides for a faster, safer, and less expensive surgicalprocedure.

Many complications can arise in trabecular meshwork surgeries, wherein aknife is first used to create an incision in the trabecular meshwork,followed by removal of the knife and subsequent installation of thestent. For instance, the knife may cause some bleeding which clouds upthe surgical site. This may require more effort and time to clean thesurgical site prior to placement of the stent. Moreover, this may causethe intraocular pressure (IOP) to rise. Thus, undesirably, such amultiple step procedure may demand crisis management which slows downthe surgery, makes it less safe, and more expensive.

FIG. 14 is a simplified partial view of an eye 10 illustrating theimplantation of a self-trephining glaucoma stent device 30 a havingfeatures and advantages in accordance with one embodiment. The stent 30a is generally similar to the stent 30 of FIGS. 3-9 except that itssnorkel 32 a comprises a longer shank 40 a which extends into Schlemm'scanal 22 and a lumen 42 a which bifurcates into two output channels 45a.

In the illustrated embodiment of FIG. 14, the shank 40 a terminates atthe blade 34. Aqueous flows from the anterior chamber 20 into the lumen42 a through an inlet port 54 a (as generally indicated by arrow 58 a).Aqueous then flows through the output channels 45 a and out ofrespective outlet ports 56 a and into Schlemm's canal 22 (as generallyindicated by arrows 60 a). The outlet channels 45 a extend radiallyoutwards in generally opposed directions and the outlet ports 56 a areconfigured to face in the general direction of the stent longitudinalaxis 36 so that they open into Schlemm's canal 22 and are in properorientation to allow aqueous outflow into Schlemm's canal 22 forlowering and/or balancing the intraocular pressure (IOP). As indicatedabove, fiducial marks or indicia and/or predetermined shapes of thesnorkel seat 38 allow for proper orientation of the blade 34 and alsothe output channels 45 a and respective ports 56 a within Schlemm'scanal.

In the illustrated embodiment of FIG. 14, two outflow channels 45 a areprovided. In another embodiment, only one outflow channel 45 a isprovided. In yet another embodiment, more than two outflow channels 45 aare provided. In modified embodiments, the lumen 42 a may extend all theway through to the blade 34 and provide an outlet port as discussedabove with reference to the embodiment of FIGS. 3-9.

FIG. 15 is a simplified partial view of an eye 10 illustrating theimplantation of a self-trephining glaucoma stent device 30 b havingfeatures and advantages in accordance with one embodiment. The stent 30b is generally similar to the stent 30 of FIGS. 3-9 except that itssnorkel 32 b comprises a longer shank 40 b which extends into Schlemm'scanal 22 and a lumen 42 b which bifurcates into two output channels 45b.

In the illustrated embodiment of FIG. 15, the shank 40 b extends throughthe blade 34. Aqueous flows from the anterior chamber 20 into the lumen42 b through an inlet port 54 b (as generally indicated by arrow 58 b).Aqueous then flows through the output channels 45 b and out ofrespective outlet ports 56 b and into Schlemm's canal 22 (as generallyindicated by arrows 60 b). The outlet channels 45 b extend radiallyoutwards in generally opposed directions and the outlet ports 56 b areconfigured to face in the general direction of the stent longitudinalaxis 36 so that they open into Schlemm's canal 22 and are in properorientation to allow aqueous outflow into Schlemm's canal 22 forlowering and/or balancing the intraocular pressure (IOP). As indicatedabove, fiducial marks or indicia and/or predetermined shapes of thesnorkel seat 38 allow for proper orientation of the blade 34 and alsothe output channels 45 b and respective ports 56 b within Schlemm'scanal.

In the illustrated embodiment of FIG. 15, two outflow channels 45 b areprovided. In another embodiment, only one outflow channel 45 b isprovided. In yet another embodiment, more than two outflow channels 45 bare provided. In modified embodiments, the lumen 42 b may extend all theway through to the blade 34 and provide an outlet port as discussedabove with reference to the embodiment of FIGS. 3-9.

FIGS. 16-20 show different views of a self-trephining glaucoma stentdevice 30 c having features and advantages in accordance with oneembodiment. The stent 30 c is generally similar to the stent 30 of FIGS.3-9 except that it has a modified blade configuration. The stent 30 ccomprises a blade 34 c which is a generally curved elongated sheet- orplate-like structure with an upper curved surface 62 c and a lowercurved surface 64 c which defines a trough or open face channel 66 c.The perimeter of the blade 34 c is generally defined by a curvedproximal edge 68 c proximate to the snorkel 32, a curved distal edge 70c spaced from the proximal edge 68 c by a pair of generally straightlateral edges 72 c, 74 c which are generally parallel to one another andhave about the same length.

In the illustrated embodiment of FIGS. 16-20, the blade 34 c comprises acutting tip 78 c. The cutting tip 78 c preferably includes cutting edgesformed on selected portions of the distal edge 70 c and adjacentportions of the lateral edges 72 c, 74 c for cutting through thetrabecular meshwork for placement of the snorkel 32. The cutting edgesare sharp edges of beveled or tapered surfaces as discussed above inreference to FIG. 9. The embodiment of FIGS. 16-20 may be efficaciouslymodified to incorporate the snorkel configuration of the embodiments ofFIGS. 14 and 15.

FIGS. 21-25 show different views of a self-trephining glaucoma stentdevice 30 d having features and advantages in accordance with oneembodiment. The stent 30 d is generally similar to the stent 30 of FIGS.3-9 except that it has a modified blade configuration. The stent 30 dcomprises a blade 34 d which is a generally curved elongated sheet- orplate-like structure with an upper curved surface 62 d and a lowercurved surface 64 d which defines a trough or open face channel 66 d.The perimeter of the blade 34 d is generally defined by a curvedproximal edge 68 d proximate to the snorkel 32, a pair of inwardlyconverging curved distal edges 70 d′, 70 d″ spaced from the proximaledge 68 d by a pair of generally straight respective lateral edges 72 d,74 d which are generally parallel to one another and have about the samelength. The distal edges 70 d′, 70 d″ intersect at a distal-most point76 d of the blade 34 d proximate a blade cutting tip 78 d.

In the illustrated embodiment of FIGS. 21-25, the cutting tip 78 dpreferably includes cutting edges formed on the distal edges 70 d′, 70d″ and extending from the distal-most point 76 d of the blade 34 d. Inone embodiment, the cutting edges extend along only a portion ofrespective distal edges 70 d′, 70 d″. In another embodiment, the cuttingedges extend along substantially the entire length of respective distaledges 70 d′, 70 d″. In yet another embodiment, at least portions of thelateral edges 72 d, 74 d proximate to respective distal edges 70 d′, 70d″ have cutting edges. In a further embodiment, the tip 78 d proximateto the distal-most end 76 d is curved slightly inwards, as indicatedgenerally by the arrow 88 d in FIG. 21 and arrow 88 d (pointedperpendicular and into the plane of the paper) in FIG. 22, relative tothe adjacent curvature of the blade 34 d.

In the embodiment of FIGS. 21-25, the cutting edges are sharp edges ofbeveled or tapered surfaces as discussed above in reference to FIG. 9.The embodiment of FIGS. 21-25 may be efficaciously modified toincorporate the snorkel configuration of the embodiments of FIGS. 14 and15.

FIGS. 26-28 show different views of a self-trephining glaucoma stentdevice 30 e having features and advantages in accordance with oneembodiment. The stent device 30 e generally comprises a snorkel 32 emechanically connected to or in mechanical communication with a blade orcutting tip 34 e. The snorkel 32 e has a seat, head or cap portion 38 emechanically connected to or in mechanical communication with a shank 40e, as discussed above. The shank 40 e has a distal end or base 47 e. Thesnorkel 32 e further has a lumen 42 e which bifurcates into a pair ofoutlet channels 45 e, as discussed above in connection with FIGS. 14 and15. Other lumen and inlet and outlet port configurations as taught orsuggested herein may also be efficaciously used, as needed or desired.

In the illustrated embodiment of FIGS. 26-28, the blade 34 e extendsdownwardly and outwardly from the shank distal end 47 e. The blade 34 eis angled relative to a generally longitudinal axis 43 e of the snorkel32 e, as best seen in FIGS. 27 and 28. The blade 34 e has a distal-mostpoint 76 e. The blade or cutting tip 34 e has a pair of side edges 70e′, 70 e″, including cutting edges, terminating at the distal-most point76 e, as best seen in FIG. 26. In one embodiment, the cutting edges aresharp edges of beveled or tapered surfaces as discussed above inreference to FIG. 9.

Referring to FIGS. 26-28, in one embodiment, the blade 34 e includescutting edges formed on the edges 70 e′, 70 e″ and extending from thedistal-most point 76 e of the blade 34 d. In one embodiment, the cuttingedges extend along only a portion of respective distal edges 70 e′, 70e″. In another embodiment, the cutting edges extend along substantiallythe entire length of respective distal edges 70 e′, 70 e″. In yetanother embodiment, the blade or cutting tip 34 e comprises a bent tipof needle, for example, a 30 gauge needle.

In general, any of the blade configurations disclosed herein may be usedin conjunction with any of the snorkel configurations disclosed hereinor incorporated by reference herein to provide a self-trephiningglaucoma stent device for making an incision in the trabecular meshworkfor receiving the corresponding snorkel to provide a pathway for aqueousoutflow from the eye anterior chamber to Schlemm's canal, therebyeffectively lowering and/or balancing the intraocular pressure (IOP).The self-trephining ability of the device, advantageously, allows for a“one-step” procedure in which the incision and placement of the snorkelare accomplished by a single device and operation. In any of theembodiments, fiducial markings or indicia, and/or preselectedconfiguration of the snorkel seat, and/or positioning of the stentdevice in a preloaded applicator may be used for proper orientation andalignment of the device during implantation.

Delivery Apparatus

In many cases, a surgeon works from a temporal incision when performingcataract or goniometry surgery. FIG. 29 illustrates a temporal implantprocedure, wherein a delivery apparatus or “applicator” 100 having acurved tip 102 is used to deliver a stent 30 to a temporal side 27 ofthe eye 10. An incision 28 is made in the cornea 10, as discussed above.The apparatus 100 is then used to introduce the stent 30 through theincision 28 and implant it within the eye 10.

Still referring in particular to FIG. 29, in one embodiment, a similarlycurved instrument would be used to make the incision through thetrabecular meshwork 21. In other embodiments, a self-trephining stentdevice 30 may be used to make this incision through the trabecularmeshwork 21, as discussed above. The temporal implantation procedureillustrated in FIG. 29 may be employed with the any of the various stentembodiments taught or suggested herein.

FIG. 30 illustrates one embodiment of an apparatus comprising anarticulating stent applicator or retrieval device 100 a. In thisembodiment, a proximal arm 106 is attached to a distal arm 108 at ajoint 112. This joint 112 is movable such that an angle formed betweenthe proximal arm 106 and the distal arm 108 can change. One or moreclaws 114 can extend from the distal arm 108, in the case of a stentretrieval device. Similarly, this articulation mechanism may be used forthe trabecular stent applicator, and thus the articulating applicator orretrieval device 100 a may be either an applicator for the trabecularstent, a retrieval device, or both, in various embodiments. Theembodiment of FIG. 30 may be employed with the any of the various stentembodiments taught or suggested herein.

FIG. 31 shows another illustrative method for placing any of the variousstent embodiments taught or suggested herein at the implant site withinthe eye 10. A delivery apparatus 100 b generally comprises a syringeportion 116 and a cannula portion 118. The distal section of the cannula118 has at least one irrigating hole 120 and a distal space 122 forholding the stent device 30. The proximal end 124 of the lumen of thedistal space 122 is sealed from the remaining lumen of the cannulaportion 118. The delivery apparatus of FIG. 30 may be employed with theany of the various stent embodiments taught or suggested herein.

In one aspect of the invention, a delivery apparatus (or “applicator”)is used for placing a trabecular stent through a trabecular meshwork ofan eye. Certain embodiments of such a delivery apparatus are disclosedin copending U.S. application Ser. No. 10/101,548, filed Mar. 18, 2002,entitled APPLICATOR AND METHODS FOR PLACING A TRABECULAR SHUNT FORGLAUCOMA TREATMENT, and U.S. Provisional Application No. 60/276,609,filed Mar. 16, 2001, entitled APPLICATOR AND METHODS FOR PLACING ATRABECULAR SHUNT FOR GLAUCOMA TREATMENT, the entire contents of each oneof which are hereby incorporated by reference herein.

FIG. 48 illustrates one embodiment of the trabecular shunt applicator502, holding the trabecular shunt 510 in place. Additionally, atrabecular meshwork blade 528 extends from the distal end of theapplicator 502. In this embodiment, the blade 528 may be extended byspring action from the distal end of the applicator 502 when theoperator pushes a button 530 or similarly actuates extension of theblade 528. The blade 528 can be retracted within the applicator 502 bymeans of a slide button 538, which the operator can move proximally toretract the blade 528. Alternatively, a plunger 532 may move the blade528 forward and backward within the applicator 502. Also shown is theouter tube 534 of the applicator 502, as well as holes 536 in theapplicator 502. These holes 536 may be used for aspiration or irrigationof the anterior chamber of the eye during the performance of trabecularmeshwork surgery.

FIG. 49A shows one embodiment of a trabecular meshwork trephine, orpunch 542. An inner tube 506 resides within an outer tube 504. The innertube 506 is in communication with an inner plunger 546. The proximal end550 of the inner plunger 546 is acted upon by a hammer 552 that isattached to a spring 548. The spring 548 may be recoiled or loaded,storing potential energy, and the hammer 552 is then held in place by anactuator 554 or other similar member in communication with the actuator554. When the actuator 554 is acted upon by an operator, the spring 548releases its potential energy, causing the hammer 552 to move forward,contacting the proximal end 550 of the inner plunger 546. This in turncauses the punch 544 to move forward, contacting the trabecularmeshwork.

FIG. 49B view is a close-up, cross-sectional view of the punch 544.Again seen as the outer tube 504, the inner tube 506, and the punch 544of the device. This trephine or punch may comprise a circular blade 556or other similar configuration known to those skilled in the art formaking a cut or punch hole in the trabecular meshwork of an eye.

FIGS. 50A and 50B illustrate embodiments of a control arm 598 which isattached to a mechanism for performing trabeculotomy. In FIG. 50A, ablade 570 extends from an end of the control arm 598. In someembodiments, the long axis of the control arm 598 runs parallel orsemiparallel to the long axis of the applicator 502. The blade 570 maybe used to make a trabeculotomy in preparation for placing thetrabecular shunt 510 through the trabecular meshwork and into Schlemm'scanal.

FIG. 50B shows a “hot tip” 571 at the end of the control arm 598. Thishot tip 571 may be a cautery, laser, or other energy transfer device formaking a hole in the trabecular meshwork in preparation for placing theshunt 510 through the trabecular meshwork and into Schlemm's canal.

FIGS. 51A through 51C illustrate various embodiments of devices, such astrephines, that can punch holes in the trabecular meshwork. In FIG. 51A,a trabecular meshwork punch 560 is illustrated. This punch 560 can makeholes 561 in the trabecular meshwork 595. These holes 561 can be ofvarious configurations, depending on the shape of the distal blade ofthe trabecular meshwork punch 560.

In FIG. 51B, a blade 566 extends from the end of a trabecular meshworkcutter 565. This blade 566 can make various punch holes 567 in thetrabecular meshwork 595, as illustrated.

FIG. 51C illustrates a trabecular meshwork drill 568. The drill 568 hasa distal drill bit 569, which can make a drill hole 561 in thetrabecular meshwork 595.

The stent has an inlet section and an outlet section. The deliveryapparatus includes a handpiece, an elongate tip, a holder and anactuator. The handpiece has a distal end and a proximal end. Theelongate tip is connected to the distal end of the handpiece. Theelongate tip has a distal portion and is configured to be placed througha corneal incision and into an anterior chamber of the eye. The holderis attached to the distal portion of the elongate tip. The holder isconfigured to hold and release the inlet section of the trabecularstent. The actuator is on the handpiece and actuates the holder torelease the inlet section of the trabecular stent from the holder. Whenthe trabecular stent is deployed from the delivery apparatus into theeye, the outlet section is positioned in substantially oppositedirections inside Schlemm's canal. In one embodiment, a deploymentmechanism within the delivery apparatus includes a push-pull typeplunger.

In some embodiments, the holder comprises a clamp. In some embodiments,the apparatus further comprises a spring within the handpiece that isconfigured to be loaded when the stent is being held by the holder, thespring being at least partially unloaded upon actuating the actuator,allowing for release of the stent from the holder.

In various embodiments, the clamp comprises a plurality of clawsconfigured to exert a clamping force onto the inlet section of thestent. The holder may also comprise a plurality of flanges.

In some embodiments, the distal portion of the elongate tip is made of aflexible material. This can be a flexible wire. The distal portion canhave a deflection range, preferably of about 45 degrees from the longaxis of the handpiece.

The delivery apparatus can further comprise an irrigation port in theelongate tip.

Some aspects include a method of placing a trabecular stent through atrabecular meshwork of an eye, the stent having an inlet section and anoutlet section, including advancing a delivery apparatus holding thetrabecular stent through an anterior chamber of the eye and into thetrabecular meshwork, placing part of the stent through the trabecularmeshwork and into a Schlemm's canal of the eye; and releasing the stentfrom the delivery apparatus.

In various embodiments, the method includes using a delivery apparatusthat comprises a handpiece having a distal end and a proximal end; anelongate tip connected to the distal end of the handpiece, the elongatetip having a distal portion and being configured to be placed through acorneal incision and into an anterior chamber of the eye; a holderattached to the distal portion of the elongate tip, the holderconfigured to hold and release the inlet section of the trabecularstent; and an actuator on the handpiece that actuates the holder torelease the inlet section of the trabecular stent from the holder.

In one aspect, the trabecular stent is removably attached to a deliveryapparatus (also known as “applicator”). When the trabecular stent isdeployed from the delivery apparatus into the eye, the outlet section ispositioned in substantially opposite directions inside Schlemm's canal.In one embodiment, a deployment mechanism within the delivery apparatusincludes a push-pull type plunger. In some embodiments, the deliveryapplicator may be a guidewire, an expandable basket, an inflatableballoon, or the like.

Other Embodiments Screw/Barb Anchored Stent:

FIGS. 32 and 33 illustrate a glaucoma stent device 30 f having featuresand advantages in accordance with one embodiment. This embodiment of thetrabecular stent 30 f includes a barbed or threaded screw-like extensionor pin 126 with barbs 128 for anchoring. The barbed pin 126 extends froma distal or base portion 130 of the stent 30 f.

In use, the stent 30 f (FIG. 32) is advanced through the trabecularmeshwork 21 and across Schlemm's canal 22. The barbed (or threaded)extension 126 penetrates into the back wall 92 of Schlemm's canal 22 upto the shoulder or base 130 that then rests on the back wall 92 of thecanal 22. The combination of a shoulder 130 and a barbed pin 126 of aparticular length limits the penetration depth of the barbed pin 126 toa predetermined or preselected distance. In one embodiment, the lengthof the pin 126 is about 0.5 mm or less. Advantageously, this barbedconfiguration provides a secure anchoring of the stent 30 f. Asdiscussed above, correct orientation of the stent 30 f is ensured byappropriate fiducial marks, indicia or the like and by positioning ofthe stent in a preloaded applicator.

Referring to FIG. 32, the aqueous flows from the anterior chamber 20,through the lumen 42 f, then out through two side-ports 56 f to bedirected in both directions along Schlemm's canal 22. Alternatively,flow could be directed in only one direction through a single side-port56 f. In other embodiments, more than two outlet ports 56 f, forexample, six to eight ports (like a pin wheel configuration), may beefficaciously used, as needed or desired.

Still referring to FIG. 32, in one embodiment, the stent 30 f isinserted through a previously made incision in the trabecular meshwork21. In other embodiments, the stent 30 f may be combined with any of theblade configurations taught or suggested herein to provideself-trephining capability. In these cases, the incision through thetrabecular meshwork 21 is made by the self-trephining stent device whichhas a blade at its base or proximate to the base.

Deeply Threaded Stent:

FIG. 34 illustrates a glaucoma stent device 30 g having features andadvantages in accordance with one embodiment. The stent 30 g has a heador seat 38 g and a shank or main body portion 40 g with a base or distalend 132. This embodiment of the trabecular stent 30 g includes a deepthread 134 (with threads 136) on the main body 40 g of the stent 30 gbelow the head 38 g. The threads may or may not extend all the way tothe base 132.

In use, the stent 30 g (FIG. 34) is advanced through the meshwork 21through a rotating motion, as with a conventional screw. Advantageously,the deep threads 136 provide retention and stabilization of the stent 30g in the trabecular meshwork 21.

Referring to FIG. 34, the aqueous flows from the anterior chamber 20,through the lumen 42 g, then out through two side-ports 56 g to bedirected in both directions along Schlemm's canal 22. Alternatively,flow could be directed in only one direction through a single side-port56 g. In other embodiments, more than two outlet ports 56 g may beefficaciously used, as needed or desired.

One suitable applicator or delivery apparatus for this stent 30 g (FIG.34) includes a preset rotation, for example, via a wound torsion springor the like. The rotation is initiated by a release trigger on theapplicator. A final twist of the applicator by the surgeon andobservation of suitable fiducial marks, indicia or the like ensureproper alignment of the side ports 56 g with Schlemm's canal 22.

Referring to FIG. 34, in one embodiment, the stent 30 g is insertedthrough a previously made incision in the trabecular meshwork 21. Inother embodiments, the stent 30 g may be combined with any of the bladeconfigurations taught or suggested herein to provide self-trephiningcapability. In these cases, the incision through the trabecular meshwork21 is made by the self-trephining stent device which has a blade at itsbase or proximate to the base.

Rivet Style Stent:

FIG. 35 illustrates a glaucoma stent device 30 h having features andadvantages in accordance with one embodiment. The stent has a base ordistal end 138. This embodiment of the trabecular stent 30 h has a pairof flexible ribs 140. In the unused state, the ribs are initiallygenerally straight (that is, extend in the general direction of arrow142).

Referring to FIG. 35, upon insertion of the stent 30 h through thetrabecular meshwork 21, the ends 144 of respective ribs 140 of the stent30 h come to rest on the back wall 92 of Schlemm's canal 22. Furtheradvancement of the stent 30 h causes the ribs 140 to deform to the bentshape as shown in the drawing of FIG. 35. The ribs 140 are designed tofirst buckle near the base 138 of the stent 30 h. Then the bucklingpoint moves up the ribs 140 as the shank part 40 h of the stent 30 h isfurther advanced through the trabecular meshwork 21.

The lumen 42 h (FIG. 35) in the stent 30 h is a simple straight hole.The aqueous flows from the anterior chamber 20, through the lumen 42 h,then out around the ribs 140 to the collector channels further alongSchlemm's canal 22 in either direction.

Referring to FIG. 35, in one embodiment, the stent 30 h is insertedthrough a previously made incision in the trabecular meshwork 21. Inother embodiments, the stent 30 h may be combined with any of the bladeconfigurations taught or suggested herein to provide self-trephiningcapability. In these cases, the incision through the trabecular meshwork21 is made by the self-trephining stent device which has a blade at itsbase or proximate to the base.

Grommet Style Stent:

FIG. 36 illustrates a glaucoma stent device 30 i having features andadvantages in accordance with one embodiment. This embodiment of thetrabecular stent 30 i includes a head or seat 38 i, a tapered baseportion 146 and an intermediate narrower waist portion or shank 40 i.

In use, the stent 30 i (FIG. 36) is advanced through the trabecularmeshwork 21 and the base 146 is pushed into Schlemm's canal 22. Thestent 30 i is pushed slightly further, if necessary, until the meshwork21 stretched by the tapered base 146 relaxes back and then contracts toengage the smaller diameter portion waist 40 i of the stent 30 i.Advantageously, the combination of the larger diameter head or seat 38 iand base 146 of the stent 30 i constrains undesirable stent movement. Asdiscussed above, correct orientation of the stent 30 i is ensured byappropriate fiducial marks, indicia or the like and by positioning ofthe stent in a preloaded applicator.

Referring to FIG. 36, the aqueous flows from the anterior chamber 20,through the lumen 42 i, then out through two side-ports 56 i to bedirected in both directions along Schlemm's canal 22. Alternatively,flow could be directed in only one direction through a single side-port56 i. In other embodiments, more than two outlet ports 56 i may beefficaciously used, as needed or desired.

Still referring to FIG. 36, in one embodiment, the stent 30 i isinserted through a previously made incision in the trabecular meshwork21. In other embodiments, the stent 30 i may be combined with any of theblade configurations taught or suggested herein to provideself-trephining capability. In these cases, the incision through thetrabecular meshwork 21 is made by the self-trephining stent device whichhas a blade at its base or proximate to the base.

Biointeractive Stent:

FIG. 37 illustrates a glaucoma stent device 30 j having features andadvantages in accordance with one embodiment. This embodiment of thetrabecular stent 30 j utilizes a region of biointeractive material 148that provides a site for the trabecular meshwork 21 to firmly grip thestent 30 j by ingrowth of the tissue into the biointeractive material148. As shown in FIG. 37, preferably the biointeractive layer 148 isapplied to those surfaces of the stent 30 j which would abut against orcome in contact with the trabecular meshwork 21.

In one embodiment, the biointeractive layer 148 (FIG. 37) may be aregion of enhanced porosity with a growth promoting chemical. In oneembodiment, a type of bio-glue 150 that dissolves over time is used tohold the stent secure during the time between insertion and sufficientingrowth for stabilization. As discussed above, correct orientation ofthe stent 30 j is ensured by appropriate fiducial marks, indicia or thelike and by positioning of the stent in a preloaded applicator.

Referring to FIG. 37, the aqueous flows from the anterior chamber 20,through the lumen 42 j, then out through two side-ports 56 j to bedirected in both directions along Schlemm's canal 22. Alternatively,flow could be directed in only one direction through a single side-port56 j. In other embodiments, more than two outlet ports 56 j may beefficaciously used, as needed or desired.

Still referring to FIG. 37, in one embodiment, the stent 30 j isinserted through a previously made incision in the trabecular meshwork21. In other embodiments, the stent 30 j may be combined with any of theblade configurations taught or suggested herein to provideself-trephining capability. In these cases, the incision through thetrabecular meshwork 21 is made by the self-trephining stent device whichhas a blade at its base or proximate to the base.

Glued or Welded Stent:

FIG. 38 illustrates a glaucoma stent device 30 k having features andadvantages in accordance with one embodiment. This embodiment of thetrabecular stent 30 k is secured in place by using a permanent(non-dissolving) bio-glue 152 or a “welding” process (e.g. heat) to forma weld 152. The stent 30 k has a head or seat 38 k and a lower surface46 k.

The stent 30 k is advanced through the trabecular meshwork 21 until thehead or seat 38 k comes to rest on the trabecular meshwork 21, that is,the head lower surface 46 k abuts against the trabecular meshwork 21,and the glue or weld 152 is applied or formed therebetween, as shown inFIG. 38. As discussed above, correct orientation of the stent 30 k isensured by appropriate fiducial marks, indicia or the like and bypositioning of the stent in a preloaded applicator.

Referring to FIG. 38, the aqueous flows from the anterior chamber 20,through the lumen 42 k, then out through two side-ports 56 k to bedirected in both directions along Schlemm's canal 22. Alternatively,flow could be directed in only one direction through a single side-port56 k. In other embodiments, more than two outlet ports 56 k may beefficaciously used, as needed or desired.

Still referring to FIG. 38, in one embodiment, the stent 30 k isinserted through a previously made incision in the trabecular meshwork21. In other embodiments, the stent 30 k may be combined with any of theblade configurations taught or suggested herein to provideself-trephining capability. In these cases, the incision through thetrabecular meshwork 21 is made by the self-trephining stent device whichhas a blade at its base or proximate to the base.

Hydrophilic Latching Stent:

FIG. 39 illustrates a glaucoma stent device 30 m having features andadvantages in accordance with one embodiment. This embodiment of thetrabecular stent 30 m is fabricated from a hydrophilic material thatexpands with absorption of water. Desirably, this would enable thedevice 30 m to be inserted through a smaller incision in the trabecularmeshwork 21. The subsequent expansion (illustrated by the smaller arrows154) of the stent 30 m would advantageously enable it to latch in placein the trabecular meshwork 21. As discussed above, correct orientationof the stent 30 m is ensured by appropriate fiducial marks, indicia orthe like and by positioning of the stent in a preloaded applicator.

Referring to FIG. 39, the aqueous flows from the anterior chamber 20,through the lumen 42 m, then out through two side-ports 56 m to bedirected in both directions along Schlemm's canal 22. Alternatively,flow could be directed in only one direction through a single side-port56 m. In other embodiments, more than two outlet ports 56 m may beefficaciously used, as needed or desired.

Still referring to FIG. 39, in one embodiment, the stent 30 m isinserted through a previously made incision in the trabecular meshwork21. In other embodiments, the stent 30 m may be combined with any of theblade configurations taught or suggested herein to provideself-trephining capability. In these cases, the incision through thetrabecular meshwork 21 is made by the self-trephining stent device whichhas a blade at its base or proximate to the base.

Photodynamic Stent:

FIG. 40 illustrates a glaucoma stent device 30 n having features andadvantages in accordance with one embodiment. This embodiment of thetrabecular stent 30 n is fabricated from a photodynamic material thatexpands on exposure to light.

It is commonly known that there is a diurnal variation in the aqueoushumor production by the eye—it is higher during the day than it is atnight. The lumen 42 n of the stent 30 n responds to light entering thecornea during the day by expanding and allowing higher flow of aqueousthrough the lumen 42 n and into Schlemm's canal 22. This expansion isgenerally indicated by the smaller arrows 156 (FIG. 40) which show thelumen 42 n (and ports) expanding or opening in response to lightstimulus. (The light or radiation energy E is generally given by E=hν,where h is Planck's constant and ν is the frequency.) At night, indarkness, the lumen diameter decreases and reduces the flow allowedthrough the lumen 42 n. In one embodiment, an excitation wavelength thatis different from that commonly encountered is provided on an as-neededbasis to provide higher flow of aqueous to Schlemm's canal 22.

This photodynamic implementation is shown in FIG. 40 for theself-latching style of stent 30 n, but can be efficaciously used withany of the other stent embodiments, as needed or desired. As discussedabove, correct orientation of the stent 30 n is ensured by appropriatefiducial marks, indicia or the like and by positioning of the stent in apreloaded applicator.

Referring to FIG. 40, the aqueous flows from the anterior chamber 20,through the lumen 42 n, then out through two side-ports 56 n to bedirected in both directions along Schlemm's canal 22. Alternatively,flow could be directed in only one direction through a single side-port56 n. In other embodiments, more than two outlet ports 56 n may beefficaciously used, as needed or desired.

Still referring to FIG. 40, in one embodiment, the stent 30 n isinserted through a previously made incision in the trabecular meshwork21. In other embodiments, the stent 30 n may be combined with any of theblade configurations taught or suggested herein to provideself-trephining capability. In these cases, the incision through thetrabecular meshwork 21 is made by the self-trephining stent device whichhas a blade at its base or proximate to the base.

Collector Channel Alignment Stent:

FIG. 41 illustrates a glaucoma stent device 30 p having features andadvantages in accordance with one embodiment. This figure depicts anembodiment of a stent 30 p that directs aqueous from the anteriorchamber 20 directly into a collector channel 29 which empties intoaqueous veins. The stent 30 p has a base or distal end 160.

In the illustrated embodiment of FIG. 41, a removable alignment pin 158is utilized to align the stent lumen 42 p with the collector channel 29.In use, the pin 158 extends through the stent lumen 42 p and protrudesthrough the base 160 and extends into the collector channel 29 to centerand/or align the stent 30 p over the collector channel 29. The stent 30p is then pressed firmly against the back wall 92 of Schlemm's canal 22.A permanent bio-glue 162 is used between the stent base and the backwall 92 of Schlemm's canal 22 to seat and securely hold the stent 30 pin place. Once positioned, the pin 158 is withdrawn from the lumen 42 pto allow the aqueous to flow directly from the anterior chamber 20 intothe collector duct 29. The collector ducts are nominally 20 to 100micrometers (μm) in diameter and are visualized with a suitablemicroscopy method (such as ultrasound biomicroscopy (UBM)) or laserimaging to provide guidance for placement of the stent 30 p.

Referring to FIG. 41, in one embodiment, the stent 30 p is insertedthrough a previously made incision in the trabecular meshwork 21. Inother embodiments, the stent 30 p may be combined with any of the bladeconfigurations taught or suggested herein to provide self-trephiningcapability. In these cases, the incision through the trabecular meshwork21 is made by the self-trephining stent device which has a blade at itsbase or proximate to the base.

Barbed Stent (Anterior Chamber to Collector Channel):

FIG. 42 illustrates a glaucoma stent device 30 q having features andadvantages in accordance with one embodiment. This figure depicts anembodiment of a stent 30 q that directs aqueous from the anteriorchamber 20 directly into a collector channel 29 which empties intoaqueous veins. The stent 30 q has a base or distal end 166 and thechannel 29 has wall(s) 164.

In the illustrated embodiment of FIG. 42, a barbed, small-diameterextension or pin 168 on the stent base 166 is guided into the collectorchannel 29 and anchors on the wall(s) 164 of the channel 29. The pin 168has barbs 170 which advantageously provide anchoring of the stent 30 q.The collector ducts 29 are nominally 20 to 100 micrometers (μm) indiameter and are visualized with a suitable microscopy method (such asultrasound biomicroscopy (UBM)) or laser imaging to provide guidance forplacement of the stent.

Referring to FIG. 42, in one embodiment, the stent 30 q is insertedthrough a previously made incision in the trabecular meshwork 21. Inother embodiments, the stent 30 q may be combined with any of the bladeconfigurations taught or suggested herein to provide self-trephiningcapability. In these cases, the incision through the trabecular meshwork21 is made by the self-trephining stent device which has a blade at itsbase or proximate to the base.

Valved Tube Stent (Anterior Chamber to Choroid):

FIG. 43 illustrates a valved tube stent device 30 r having features andadvantages in accordance with one embodiment. This is an embodiment of astent 30 r that provides a channel for flow between the anterior chamber20 and the highly vascular choroid 17. Clinically, the choroid 17 can beat pressures lower than those desired for the eye 10. Therefore, thisstent 30 r includes a valve with an opening pressure equal to thedesired pressure difference between the choroid 17 and the anteriorchamber 10 or a constriction that provide the desired pressure drop.

Osmotic Membrane (Anterior Chamber to Choroid):

FIG. 44 illustrates an osmotic membrane device 30 s having features andadvantages in accordance with one embodiment. This embodiment provides achannel for flow between the anterior chamber 20 and the highly vascularchoroid 17. The osmotic membrane 30 s is used to replace a portion ofthe endothelial layer of the choroid 17. Since the choroid 17 is highlyvascular with blood vessels, the concentration of water on the choroidside is lower than in the anterior chamber 20 of the eye 10. Therefore,the osmotic gradient drives water from the anterior chamber 20 into thechoroid 17.

Clinically, the choroid 17 (FIG. 44) can be at pressures lower thanthose desired for the eye 10. Therefore, desirably, both osmoticpressure and the physical pressure gradient are in favor of flow intothe choroid 17. Flow control is provided by proper sizing of the area ofthe membrane,—the larger the membrane area is the larger the flow ratewill be. This advantageously enables tailoring to tune the flow to thedesired physiological rates.

Ab Externo Insertion of Stent via Small Puncture:

FIG. 45 illustrates the implantation of a stent 30 t using an ab externoprocedure having features and advantages in accordance with oneembodiment. In the ab externo procedure of FIG. 45, the stent 30 t isinserted into Schlemm's canal 21 with the aid of an applicator ordelivery apparatus 100 c that creates a small puncture into the eye 10from outside.

Referring to FIG. 45, the stent 30 t is housed in the applicator 100 c,and pushed out of the applicator 100 c once the applicator tip is inposition within the trabecular meshwork 21. Since the tissue surroundingthe trabecular meshwork 21 is optically opaque, an imaging technique,such as ultrasound biomicroscopy (UBM) or a laser imaging technique, isutilized. The imaging provides guidance for the insertion of theapplicator tip and the deployment of the stent 30 t. This technique canbe used with a large variety of stent embodiments with slightmodifications since the trabecular meshwork 21 is punctured from thescleral side rather than the anterior chamber side in the ab externoinsertion.

FIG. 46 a glaucoma stent device 30 u having features and advantages inaccordance with a modified embodiment. This grommet-style stent 30 u forab externo insertion is a modification of the embodiment of FIG. 36. Inthe embodiment of FIG. 46, the upper part or head 38 u is tapered whilethe lower part or base 172 is flat, as opposed to the embodiment of FIG.36. The stent 30 u is inserted from the outside of the eye 10 through apuncture in the sclera. Many of the other embodiments of stents taughtor suggested herein can be modified for similar implantation.

This ultra-microscopic device 30 u (FIG. 46) can be used with (1) atargeting Lasik-type laser, or with (2) contact on eyes or with (3)combined ultrasound microscope or (4) other device insertor handpiece.

Targeted Drug Delivery to the Trabecular Meshwork:

FIG. 47 illustrates a targeted drug delivery implant 30 v havingfeatures and advantages in accordance with one embodiment. This drawingis a depiction of a targeted drug delivery concept. The slow releaseimplant 30 v is implanted within the trabecular meshwork 21.

A drug that is designed to target the trabecular meshwork 21 to increaseits porosity, or improve the active transport across the endotheliallayer of Schlemm's canal 22 can be stored in this small implant 30 v(FIG. 47). Advantageously, slow release of the drug promotes the desiredphysiology at minimal dosage levels since the drug is released into thevery structure that it is designed to modify.

While the components and techniques of the invention have been describedwith a certain degree of particularity, it is manifest that many changesmay be made in the specific designs, constructions and methodologyherein above described without departing from the spirit and scope ofthis disclosure. It should be understood that the invention is notlimited to the embodiments set forth herein for purposes ofexemplification, but is to be defined only by a fair reading of theappended claims, including the full range of equivalency to which eachelement thereof is entitled.

1. A system for implanting a device into the eye, comprising: a deviceconfigured to be implanted in the eye such that a first end of thedevice is in communication with the choroid, the device having a lumenwherein a first end of the lumen of the device communicates with thechoroid and a second end of the lumen of the device opens into theanterior chamber when implanted in the eye such that the lumen providesa flow pathway from the anterior chamber towards the choroid, so as toprovide intraocular pressure balancing by providing aqueous humoroutflow from the anterior chamber towards the choroid through the lumen,said device configured to be inserted into the eye through aself-sealing incision in the cornea and wherein the device has a secondend configured to reside in the anterior chamber when in an implantationlocation; and a delivery apparatus comprising an elongate tip that isremovably attached to the device, wherein the delivery apparatus isconfigured to introduce the device into the anterior chamber through thecorneal incision, advance the device through the anterior chamber,advance the implant through an opening formed in eye tissue, and releasethe device from the elongate tip and into the implantation location.2.-10. (canceled)
 11. The system of claim 1, wherein, when the device isin communication with the choroid, at least a portion of the device isin contact with the choroid. 12.-20. (canceled)
 21. The system of claim1, wherein the first end of the device is configured to be located so asto be in communication with the uveal scleral outflow route, wherein thesecond end of the device resides entirely within the confines of thesclera and the cornea upon implantation, and wherein the deliveryapparatus further comprises a blade or cannula configured to detach atleast a portion of the ciliary body from the sclera to form an internalspace between the ciliary body and the sclera into which the device maybe placed. 22-23. (canceled)
 24. A system for implanting a device intothe eye, comprising: a device for establishing an outflow pathwayconfigured to be implanted in the eye so as to locate a first end of thedevice in communication with the choroid, the device having a lumenwherein a first end of the lumen of the device communicates with thechoroid and a second end of the lumen of the device opens into theanterior chamber when implanted in an implantation location in the eyesuch that the lumen provides a flow pathway from the anterior chambertowards the choroid, so as to provide intraocular pressure balancing byproviding aqueous humor outflow from the anterior chamber towards thechoroid through the lumen, wherein the device has a second endconfigured to reside in the anterior chamber, wherein the device isconfigured to be implanted into the eye through an incision in thecornea; and a delivery apparatus comprising an elongate tip that isremovably attached to the device, wherein the delivery apparatus isconfigured to advance the device through the corneal incision and intothe anterior chamber, advance the device through the anterior chamber,advance the device through an opening formed in eye tissue, and releasethe device from the elongate tip and into the implantation location.25.-27. (canceled)
 28. The system of claim 24, wherein the device has anexternal diameter sized such that the device can be inserted through acorneal incision of less than about 1 mm.
 29. The system of claim 24,wherein the device has a length that extends from the anterior chamberto the choroid when implanted.
 30. (canceled)
 31. The system of claim24, wherein the device is a tube.
 32. (canceled)
 33. The system of claim24, wherein, when the device is in communication with the choroid, atleast a portion of the device is in contact with the choroid. 34.-42.(canceled)
 43. The system of claim 24, wherein the second end of thedevice resides entirely within the confines of the sclera and the corneaupon implantation, and wherein the delivery apparatus further comprisesa blade or cannula that is configured to detach at least a portion ofthe ciliary body from the sclera to form an internal space between theciliary body and the sclera into which the device may be placed. 44.-84.(canceled)
 85. A system, comprising: an implant comprising an elongateddevice having a second end region, a first end region, and an lumencommunicating with an inlet port in the second end region and an outletport in the first end region, the implant configured to be advanced intothe anterior chamber of the eye via an incision in the cornea andpositioned in an implantation location wherein the inlet port is in theanterior chamber of the eye and the outlet port is in communication withthe choroid and at least a portion of the implant is in contact with aninner surface of sclera of the eye so that the lumen provides a flowpathway from the anterior chamber towards the choroid; and a deliveryapparatus comprising an elongate tip that is removably attached to theimplant, wherein the delivery apparatus is configured to advance theimplant through the corneal incision and into the anterior chamber,advance the implant through the anterior chamber, advance the devicethrough an opening formed in eye tissue, and release the implant fromthe elongate tip and into the implantation-location.
 86. (canceled) 87.(canceled)
 88. A system as in claim 85, wherein the delivery apparatuscomprises a cannula.
 89. A system as in claim 85, wherein the deliveryapparatus is configured to introduce the implant into the anteriorchamber through a self-sealing corneal incision.
 90. (canceled)
 91. Thesystem of claim 85, wherein, when the device is in communication withthe choroid, at least a portion of the device is in contact with thechoroid. 92.-98. (canceled)
 99. The system of claim 85, wherein thefirst end of the device is located so as to be in communication with auveal scleral outflow route, wherein the delivery apparatus furthercomprises a blade or cannula configured to detach at least a portion ofthe ciliary body from the sclera to form an internal space between theciliary body and the sclera into which the device may be placed.100.-118. (canceled)
 119. A system for implanting a device into the eye,comprising: a device for establishing an outflow pathway configured tobe implanted in the eye so as to locate a first end of the device incommunication with a uveal scleral outflow route, the device having alumen wherein a first end of the lumen of the device communicates withthe uveal scleral outflow route and a second end of the lumen of thedevice opens into the anterior chamber when implanted in an implantationlocation in the eye such that the lumen provides a flow pathway from theanterior chamber towards the uveal scleral outflow route, so as toprovide aqueous pressure balancing by providing aqueous outflow from theanterior chamber towards the uveal scleral outflow route through thelumen, wherein the device has a second end configured to reside in theanterior chamber, wherein the device is configured to be implanted intothe eye through an incision in the cornea; and a delivery apparatuscomprising an elongate tip that is removably attached to the device,wherein the delivery apparatus is configured to advance the devicethrough the corneal incision and into the anterior chamber, advance thedevice through the anterior chamber, advance the device through anopening formed in eye tissue, and release the device from the elongatetip and into the implantation location.
 120. (canceled)
 121. (canceled)122. (canceled)
 123. The system of claim 119, wherein the device has anexternal diameter sized such that the device can be inserted through acorneal incision of less than about 1 mm. 124.-127. (canceled)
 128. Thesystem of claim 119, wherein, when the device is in communication withthe uveal scleral outflow route, at least a portion of the device is incontact with the choroid. 129.-133. (canceled)
 134. The system of claim119, wherein the second end of the device resides entirely within theconfines of the sclera and the cornea upon implantation, and wherein thedelivery apparatus further comprises a blade or cannula that isconfigured to detach at least a portion of the ciliary body from thesclera to form an internal space between the ciliary body and the sclerainto which the device may be placed. 135.-170. (canceled)
 171. A system,comprising: an implant comprising an elongated device having a secondend region, a first end region, and an lumen communicating with an inletport in the second end region and an outlet port in the first endregion, the implant configured to be advanced into the anterior chamberof the eye via an incision in the cornea and positioned in a locationwherein the inlet port is in the anterior chamber of the eye and theoutlet port is in communication with a uveal scleral outflow route andat least a portion of implant is in contact with an inner surface ofsclera of the eye so that the lumen provides a flow pathway from theanterior chamber towards the uveal scleral outflow route; and a deliveryapparatus comprising an elongate tip that is removably attached to theimplant, wherein the delivery apparatus is configured to advance theimplant through the corneal incision and into the anterior chamber,advance the implant through the anterior chamber, advance the implantthrough an opening formed in eye tissue, and release the implant fromthe elongate tip and into the implantation-location.
 172. (canceled)173. (canceled)
 174. A system as in claim 171, wherein the deliveryapparatus comprises a cannula.
 175. A system as in claim 171, whereinthe delivery apparatus is configured to introduce the implant into theanterior chamber through a self-sealing corneal incision. 176.-181.(canceled)
 182. The system of claim 24, wherein the device is configuredto be positioned in the anterior chamber such that the second end isoutside of the ciliary body and posterior of an inner surface of thecornea.
 183. (canceled)
 184. (canceled)
 185. The system of claim 85,wherein the device is configured to be positioned in the anteriorchamber such that the second end is outside of the ciliary body andposterior of an inner surface of the cornea.
 186. The system of claim119, wherein the device is configured to be positioned in the anteriorchamber such that the second end is outside of the ciliary body andposterior of an inner surface of the cornea.
 187. (canceled) 188.(canceled)
 189. The system of claim 171, wherein the device isconfigured to be positioned in the anterior chamber such that the secondend is outside of the ciliary body and posterior of an inner surface ofthe cornea.